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InTray™ GC 1080

by Diagnostic Consulting Network, LLC.

Ref 10-8000Model 1080

InTray™ GC 1080 (10-8000) is a device classified as IVD General (EU), Class II (US) made by Diagnostic Consulting Network, LLC., registered in EUDAMED on 5 Aug 2026 (Basic UDI-DI B-B08810800), cleared under FDA 510(k) K993033 on 16 Dec 1999 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI B08810800), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K993033

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-B08810800 Basic UDI-DI B08810800UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB08810800 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK993033 Date16 Dec 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-B08810800 registered 5 Aug 2026 Active
  • FDA 510(k) K993033 decided 16 Dec 1999 Active
  • FDA GUDID UDI-DI B08810800 listed 21 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K993033
  2. Listed FDA GUDID B08810800
  3. Registered EUDAMED B-B08810800

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
InTray™ GC
Generic name
Neisseria gonorrhoeae culture isolate identification IVD, kit
Model / Ref / Catalog
1080, 10-8000
Primary DI / UDI-DI
B08810800
Basic UDI-DI
B-B08810800
510(k) Number
FDA product code
JTY
EMDN code
W02039085 Various microbiology instruments - consumables
GMDN term
Neisseria gonorrhoeae culture isolate identification IVD, kit
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.2410
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Neisseria gonorrhoeae culture isolate identification IVD, kit

Similar devices in this category

Other devices filed under VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES.

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Properties

  • Single use
  • Contains substances of microbial origin
  • IVD kit
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)